# K012387: STG Multichannel Lung Sound Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Stethographics, Inc.
- Decided: Apr 23, 2002 after 270 days
- Product code: BZM (Calculator, Pulmonary Function Interpretor (Diagnostic))
- Device class: 2
- Regulation: 21 CFR 868.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980878 (1998). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980878: Pulmotrack,Model 1010, Karmel Medical Acoustic Technologies, Ltd. (1998). Our OCR of the scanned summary read K980978, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pulmotrack, Model 1010”.

## Most influential descendants
- K090863: Personal Wheezometer (2009), 8 descendants of its own
- K131285: Sonosentry (2014), 7 descendants of its own
- K202062: wheezo WheezeRate Detector (2021), 6 descendants of its own
- K221614: TytoCare Lung Sounds Analyzer (2023), 5 descendants of its own
- K232237: Tyto Insights for Wheeze Detection (2023), 4 descendants of its own

## Indications for use
The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.

Source page: https://510kreport.com/device/K012387
Methodology: https://510kreport.com/methodology